FDA warning letter consistency audit by HHS Inspector General under way.
This article was originally published in The Tan Sheet
Executive Summary
FDA WARNING LETTER CONSISTENCY AUDIT BY HHS INSPECTOR GENERAL will study several FDA district offices to determine whether uniform criteria are used in issuing warning letters. The investigation will evaluate warning letters issued to all industries regulated by FDA, including OTC drugs and dietary supplements. The IG has conducted an entrance interview with FDA's Office of Regulatory Affairs, which oversees field operations, and has asked for information contained in the agency's warning letter database.